Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma

NCT ID: NCT00406757

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-30
• Study Completion Date: 2009-07-15

Brief Summary

In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small patient population. While the small number of patients presents a practical limitation to the size of a clinical trial, patients whose disease has not responded to or has relapsed after treatment with multiple prior chemotherapy regimens have no accepted standard therapies available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability, and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize the contribution of each available patient.

Conditions

Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic

Keywords

T-cell; T-ALL; T-LBL; 506U78; ara-G; ara-GTP; Lymphoma; Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pediatric Arm 1

Cycle 1: Nelarabine 400mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose.

Cycle 2 and subsequent Cycles: Nelarabine 650mg2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose.

Group Type: ACTIVE_COMPARATOR

Nelarabine injection 400mg/m2

Intervention Type: DRUG

Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5.

Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5.

Pediatric Arm 2

Cycle 1 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose.

Group Type: ACTIVE_COMPARATOR

Nelarabine injection 650mg/m2

Intervention Type: DRUG

Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.

Adult Arm 1

Cycle 1: Nelarabine 1000mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose.

Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose.

Group Type: ACTIVE_COMPARATOR

Nelarabine injection 1000mg/m2

Intervention Type: DRUG

Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5.

Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.

Adult Arm 2

Cycle 1 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose.

Group Type: ACTIVE_COMPARATOR

Nelarabine injection 1500mg/m2

Intervention Type: DRUG

Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.

Pediatric Arm 3

Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.

Group Type: ACTIVE_COMPARATOR

Nelarabine injection 650mg/m2

Intervention Type: DRUG

Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.

Interventions

Nelarabine injection 400mg/m2

Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5.

Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5.

Intervention Type: DRUG

Nelarabine injection 650mg/m2

Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.

Intervention Type: DRUG

Nelarabine injection 1000mg/m2

Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5.

Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.

Intervention Type: DRUG

Nelarabine injection 1500mg/m2

Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologic or cytogenetic documented diagnosis of T-ALL or T-LBL.
• Disease that is refractory to at least one prior chemotherapy regimen, or has relapsed following complete remission to at least one prior chemotherapy regimen.
• At least 4 weeks since the last dose of prior last chemotherapy, or radiotherapy before beginning treatment with 506U78 (2 weeks is permitted if growth of blast cells is significant).
• Adequate function of other organ systems as measured as follows.Serum creatinine is less than 1.5 times of upper limit of normal and estimated creatinine clearance >=50 mL/min. Hepatic transaminases (SGPT and SGOT) <=3 x upper limit of normal, bilirubin is less than 1.5 times of upper limit of normal(<=5 x upper limit of normal if it is related by T-ALL or T-LBL).
• Adequate performance status (ECOG-PS<=2).
• Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
• Patient is willing to accept hospitalization during the blood sampling for pharmacokinetic measurement (i.e., Cohort 1: for pharmacokinetic sample collection during both cycle 1 and 2; and Cohort 2: for pharmacokinetic sample collection during cycle 1).
• Female subjects who are of child-bearing potential must have a negative pregnancy test at the Screening Visit and agree to utilize contraceptive methods during participation in the study and for at least six months following the last dose of 506U78 Injection. Female subjects may be defined as of non-child-bearing potential if they are physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses.

Exclusion Criteria

• Active infection at time of treatment.
• Concurrent disease or condition that would make the subject inappropriate for study participation.
• Receiving any other anticancer agents or enrolled on any investigational study during the course of the study.
• Patients must have recovered to Grade I or less toxicity of all previous chemotherapy prior to treatment.
• History of seizure disorder within one year prior to the date of informed consent.
• Pregnancy (as demonstrated by a positive pregnancy test at pre-study/screening) or breastfeeding. Fertile women and men must practice adequate contraception throughout the study and at least 6 month after the last dose of study drug.

• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

Countries

Japan

References

Horibe K, Takimoto T, Yokozawa T, Makimoto A, Kobayashi Y, Ogawa C, Ohno R, Koh N, Katsura K, Tobinai K. Phase I study of nelarabine in patients with relapsed or refractory T-ALL/T-LBL. Rinsho Ketsueki. 2011 Jun;52(6):406-15.

Reference Type: BACKGROUND

PMID: 21737993 (View on PubMed)

Other Identifiers

PGA105446

Identifier Type: -

Identifier Source: org_study_id